A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Chronic Rhinosinusitis Without Nasal Polyps Clinical Trial

— BiRCh  

Official title:

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps - The BiRCh Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013241
• Other study ID #: INS1007-221
• Secondary ID: 2022-502481-24-0
• Status: Recruiting
• Phase: Phase 2
• Start date: October 30, 2023
• Est. completion date: September 25, 2025

Study information

• Verified date: June 2024
• Source: Insmed Incorporated
• Contact: Insmed Medical Information
• Phone: 1-844-446-7633
• Email: medicalinformation[@]insmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving clinical symptoms of CRSsNP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: September 25, 2025
• Est. primary completion date: August 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants who have at least a 12-week history before Screening Visit of CRSsNP and confirmed by endoscopy at Visit 1 (Screening).

• Participants must have a NCS of =2 at Visit 1 (Screening Visit) and Visit 2 (weekly average score).

• Participants must have sTSS (nasal congestion [NC], anterior/posterior rhinorrhea, facial pain/pressure) =5 at Visit 1 (Screening) and at Visit 2 (Baseline) (average score in the week prior to randomization).

• Participants who have at least 1 of the 3 following features:

1. Previous sinonasal surgery for CRS, including but not limited to fenestrated endoscopic sinus surgery and balloon sinuplasty.

2. Received medical treatment with systemic corticosteroids (SCS) to treat symptoms of CRS as defined by any dose and duration within 1 year of Screening Visit or intolerance/contraindication to SCS.

3. Received a course of antibiotics to treat symptoms of CRS within 1 year before the Screening Visit.

• Participants who have a blood eosinophil count =750 cells/microliter (µL) at Visit 1 (Screening).

• Participants who have bilateral inflammation of paranasal sinuses in the CT scan performed during Screening and bilateral ethmoid and/or maxillary opacification before randomization as confirmed by the central reader.

• Participants who have a SNOT-22 score of =20 at Visit 1 (Screening) and Visit 2 (Baseline).

• Participants who have received a stable daily dose regimen of MFNS for at least 4 weeks before Visit 2 (Baseline).

Exclusion Criteria:

• Diagnosis of unilateral or bilateral chronic rhinosinusitis with nasal polyps (CRSwNP).

• Clinical diagnosis of cystic fibrosis (CF) or primary ciliary dyskinesia.

• Scheduled sinus surgery at any time during the study.

• Participants who have had nasal surgery within 4 weeks before Visit 1 (Screening) and during the Screening Period.

• Significant oral maxillofacial structural abnormalities or severe septal deviation.

• Participants with radiological suspicion or confirmed invasive fungal rhinosinusitis, odontogenic sinusitis, osteomas, or nasal tumors.

• Participants with acute change in symptoms consistent with acute rhinosinusitis.

• Participants with seasonal allergic rhinitis whose symptoms coincide with the treatment period of the study.

• Participants with moderate to severe atopic dermatitis requiring treatment with high potency topical steroids or topical calcineurin inhibitors or biologics.

• Clinical diagnosis of Papillon-Lefèvre syndrome. Note: Other inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis Without Nasal Polyps
• Nasal Polyps
• Polyps
• Rhinosinusitis
• Sinusitis

Intervention

Drug:
• Brensocatib
Film-coated tablet.
• Placebo
Film-coated tablet.
• Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.

Locations

Country	Name	City	State
Argentina	ARG005	Ciudad Autónoma de Buenos Aires	Ciudad Autónoma De BuenosAires
Argentina	ARG011	Ciudad Autónoma de Buenos Aires	Ciudad Autónoma De BuenosAires
Argentina	ARG012	Ciudad Autónoma de Buenos Aires	Ciudad Autónoma De BuenosAires
Argentina	ARG001	La Plata	Buenos Aires
Argentina	ARG006	Lobos	Buenos Aires
Argentina	ARG002	Mar del Plata
Argentina	ARG003	Mendoza
Argentina	ARG014	Mendoza
Argentina	ARG004	Rosario	Santa Fe
Argentina	ARG007	Rosario	Santa Fe
Argentina	ARG010	Rosario	Santa Fe
Argentina	ARG009	San Miguel De Tucumán	Tucumán
Argentina	ARG013	San Rafael	Mendoza
Argentina	ARG008	Santa Fe
Australia	AUS004	Birtinya	Queensland
Australia	AUS001	Herston	Queensland
Australia	AUS002	Spearwood	Western Australia
Bulgaria	BGR003	Plovdiv
Bulgaria	BGR002	Sofia	Sofia-Grad
Bulgaria	BGR005	Sofia	Sofia-Grad
Bulgaria	BGR001	Stara Zagora
Bulgaria	BGR006	Stara Zagora
Canada	CAN006	London	Ontario
Canada	CAN002	Quebec
Czechia	CZE005	Nový Hradec Králové
Czechia	CZE002	Olomouc	Olomoucký Kraj
Czechia	CZE003	Pardubice	Pardubický Kraj
Czechia	CZE004	Prague
France	FRA004	La Roche-sur-Yon	Vendée
France	FRA003	Marseille	Bouches-du-Rhône
France	FRA001	Nantes	Loire-Atlantique
Italy	ITA003	Pisa	Toscana
Italy	ITA001	Rozzano	Lombardia
Italy	ITA002	Sassari	Sardegna
Italy	ITA004	Siena	Toscana
Poland	POL004	Bialystok	Podlaskie
Poland	POL006	Katowice	Slaskie
Poland	POL005	Kraków	Malopolskie
Poland	POL003	Lublin	Lubelskie
Poland	POL002	Poznan	Wielkopolskie
Poland	POL010	Poznan	Wielkopolskie
Poland	POL001	Warszawa	Mazowieckie
Poland	POL008	Warszawa
Poland	POL007	Wieliczka	Malopolskie
Poland	POL009	Wroclaw	Dolnoslaskie
Portugal	PRT004	Aveiro
Portugal	PRT002	Braga
Portugal	PRT001	Guimarães	Braga
Portugal	PRT003	Lisbon	Lisboa
Portugal	PRT005	Senhora Da Hora	Porto
Spain	ESP002	Jerez de la Frontera	Cádiz
Spain	ESP004	Malaga	Málaga
Spain	ESP003	Santander	Cantabria
Spain	ESP001	Sevilla
United States	USA016	Boca Raton	Florida
United States	USA023	Charleston	South Carolina
United States	USA021	Chicago	Illinois
United States	USA010	Colorado Springs	Colorado
United States	USA011	Columbia	Missouri
United States	USA025	Dallas	Texas
United States	USA015	Hershey	Pennsylvania
United States	USA019	Hollywood	Florida
United States	USA018	Houston	Texas
United States	USA029	Houston	Texas
United States	USA001	Miami	Florida
United States	USA003	New Albany	Indiana
United States	USA005	Norfolk	Virginia
United States	USA022	North Charleston	South Carolina
United States	USA002	Roseville	California
United States	USA024	Saint Louis	Missouri
United States	USA030	San Antonio	Texas
United States	USA009	Tampa	Florida
United States	USA034	Tucson	Arizona
United States	USA004	Tulsa	Oklahoma
United States	USA028	Tulsa	Oklahoma
United States	USA006	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Canada,  Czechia,  France,  Italy,  Poland,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24		Baseline and Week 24
Secondary	Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at Week 24	The computed tomography (CT) scan performed during Screening (considered as Baseline) and at Week 24 will be used for the volumetric assessment of maxillary and ethmoid sinus opacification.	Baseline and Week 24
Secondary	Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24		Baseline and Week 24
Secondary	Participant Status Indicator Assessed as Percentage of Participants Requiring Rescue (Antibiotics, Systemic Corticosteroids [SCS], and/or Nasal Surgery) due to Worsening of any Chronic Rhinosinusitis (CRS) Symptoms		Baseline to Week 24
Secondary	Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24		Baseline and Week 24
Secondary	Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24		Baseline and Week 24
Secondary	Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24		Baseline and Week 24
Secondary	Plasma Concentration of Brensocatib		Pre-dose and at multiple timepoints post-dose up to Week 24
Secondary	Percentage of Participants who Experienced at Least One Adverse Event (AE)	Determination of the safety and tolerability of brensocatib compared with placebo.	Up to 28 weeks

External Links

•   Prescreening tool